Regulatory News

Regulatory publications or updates of recommendations, guidelines and reports affecting research in the 3Rs.

Eawag researchers receive ISO certification for non-animal water toxicity test

Environmental toxicology specialists at the Federal Institute of Aquatic Science and Technology (Eawag) have received international certification for a non-animal test used to determine acute toxicity of water samples and chemicals to fish. According to Eawag this is the first time a toxicity test with cultured gill cell lines from fish has been ISO-certified. There still is a lack of recognised alternatives to experiments with live fish. In 2017, researchers in Switzerland carried out more than 7,500 ecotoxicological tests with the aim of protecting humans, animals and the environment. Eawag has been researching alternatives to reduce or replace fish experiments. One of these alternatives involves experiments with a gill cell line of rainbow trout (RTgill W1 cell line). The test saves time, is cost-effective and does not require any laboratory animals. More info:

Parliamentary commission rejects initiative banning most severe experiments

The Science, Education and Culture Committee (SECC) recommends the Swiss National Council reject a parliamentary initiative requesting to ban the most severe constraints in animal experimentations. The initiative, submitted by Maya Graf of the Green Party, aims to ban animal experiments classified as severity 3, which cause medium to long-term moderate pain, suffering, injury or severe fear or health impairment. The National Council will discuss the initiative in the autumn. More info:

FSVO symposium on alternatives to carbon dioxide on 5 June 2019 in Bern

The Federal Food Safety and Veterinary Office will host the 3R Symposium on Alternatives to Carbon Dioxide on 5 June 2019 at the Campus Liebefeld in Bern. After an introduction on the challenges, speakers will present a systematic review of carbon dioxide in mice and rats as well as the revised euthanasia guideline published by the American Veterinary Medical Association. The organisers then plan to present a first draft of a research strategy to replace the use of carbon dioxide with alternatives for all animal species and all purposes, and participants will be able to comment. More information will follow over the coming weeks. 
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EURL ECVAM publishes 2018 Status Report on progress made in replacement

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) published its 2018 status report where it provides updates on the progress made in the development, validation and regulatory acceptance and use of alternative methods and approaches and their dissemination. The status report describes research, development and validation activities, as well as on initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. More info:

EFSA publishes guidance on how to communicate scientific uncertainty

Different audiences can better understand scientific uncertainties when expressions and communications formats are tailored to their needs. The European Food and Safety Authority’s new and targeted approach to uncertainty communication will help communicators to further boost the transparency of its scientific advice. The communication approach aims to increase understanding of how scientific experts express their confidence in the methods and underlying scientific evidence used in their assessments, and in their conclusions about potential risks. More info:

EDQM welcomes WHO recommendation to end innocuity test in vaccines, biologicals

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents. The ECBS bases its recommendations on the consideration that the omission of the abnormal toxicity test would not compromise the quality and safety of vaccines and other biological products. Animal tests such as the abnormal toxicity test were developed for the safety testing of human vaccines at a time when limited scientific knowledge for the quality control of biological products existed. Over the past decades, researchers have identified viable alternatives, and current manufacturing processes, including the Good Manufacturing Practices (GMP) and in-process quality controls, can ensure a more appropriate level of quality and safety for vaccines and other biological products than the abnormal toxicity test. More info:

Updated Guidance for the testing of cosmetics ingredients and their safety evaluation

The updated notes of guidance from the Scientific Committee on Consumer Safety (SCC) has published. In this 10th revision, the state-of-the-art with respect to the validated methods of the 3Rs (Refinement, Reduction and Replacement) strategy of Russell et al. (1959), is incorporated with emphasis on New Approach Methodologies (NAMs). In view of the testing and marketing bans in the cosmetic regulation, the SCCS gives special attention to those alternative methods that are suitable for the safety testing of cosmetic substances. More info:

International Guidance Document N. 286 on Good In Vitro Method Practices (GIVIMP)

The Organisation for Economic Cooperation and Development (OECD) has published a new Guidance Document (n. 286) on Good In Vitro Method Practices to promote the reliability and integrity of in vitro data used for the safety assessment of chemicals. The document aims at providing technical guidance in order to advance the development of robust and reliable in vitro methods suitable for regulatory purposes. The guidance is targeted primarily at users that implement in vitro methods, but also provides guidance for in vitro method developers. The document contains among others: – Detailed updated information on good practices for in vitro methods; – Description of the key aspects that may impact the reliability and relevance of in vitro data; – Guidance to help ensure that Standard Operating Procedures (SOPs) are well designed, robust, well defined and described. – Description of the importance of reporting criteria, applying good experimental design, establishing acceptance criteria, and performance standards based on scientific evidence from the generated in vitro datasets. More info.

The Federal Office publishes animal protection report 2018

The Federal Food Safety and Veterinary Office (FSVO) and the cantonal and national veterinary services are jointly responsible for an efficient animal welfare in line with the Swiss Animal Protection Act. The Swiss animal protection report 2018, which the FSVO just published in 3 / 4 German, French and Italian, gives an overview of the recently completed and still running projects, including a section about the Swiss 3RCC. More info.

SCHEER – Memorandum on weight of evidence and uncertainties – Revision 2018

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published the Memorandum on weight of evidence and uncertainties. The Memorandum explains how the SCHEER applies the weight of evidence 2 / 5 approach (WoE) and how it deals with analysis and description of uncertainties when conducting risk assessments of stressors to which humans and/or the environment might be exposed. More info.